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Completed

NCT Number: NCT02673112

Study of an Exercise Program (STEP) for Youth With Concussion

To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms.

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Key information

Conditions

Persistent Concussion Symptoms Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Post-Concussion Syndrome Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98136, United States

About this study

This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). The investigators are utilizing an active control (light stretching). The primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI) in the first month after randomization. Long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sports-related concussion that occurred 1-6 months inclusive prior to the start of the study, and was diagnosed by a clinician trained in concussion management consistent with the Zurich definition of concussion ("a complex pathophysiological process affecting the brain, induced by biomechanical forces [that] results in a graded set of clinical symptoms that may or may not involve loss of consciousness")
  • Persistent symptoms as defined by the presence of at least 2 concussive symptoms (from the Health Behavior Inventory, or HBI) at the time of recruitment which were not present prior to injury
  • 11 to 18 years of age (inclusive) at time of recruitment

Exclusion criteria

  • Non-English speaking youth or parents
  • Unwilling or unable to travel to Seattle Children's Hospital or Seattle Children's Research Institute twice during the course of the study
  • Cervical spine or vestibular issues requiring further targeted intervention
  • Other injuries or medical conditions in addition to concussion which would preclude vigorous exercise
  • Psychiatric hospitalization in the year prior to enrollment
  • Significant cognitive deficits such as mental retardation or autism
  • Lack of worsening of concussive symptoms with exertion
  • Significant abnormalities on routine brain imaging.

Treatment and study plan

Subthreshold exercise (STEP) with mobile health coaching

Behavioral

Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching

Light stretching (LS)

Behavioral

Brief daily stretching routine.

Primary outcomes

  1. Health Behavior Inventory (HBI)

    Time frame: Baseline, Weekly from 1-6 weeks, 3 months, 6 months

    Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI.

Secondary outcomes

  1. PedsQL

    Time frame: Baseline, 6 weeks, 3 and 6 months

    Health related quality of life

  2. Fear of Pain Questionniare (FOPQ), child and parent

    Time frame: Trajectory from baseline, 6 weeks, 3 months, 6 months

    Measure of fear avoidance

  3. Moderate-vigorous physical activity (MVPA)

    Time frame: Baseline and 6 weeks

    Hip-mounted research grade accelerometry

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Acronym: STEP

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 3, 2016
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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